1.Establish and manage newly established Cell Therapy Quality Assurance department and quality system
2.Responsible for reviewing and approving SOPs , batch records and ensuring the operation complies with GMP regulations.
3.Responsible for ensuring that raw materials, packaging materials and intermediate, bulk and finished product are approved or rejected, stored, distributed and subsequently handled according to the SOP and specifications.
4.Responsible for reviewing and approving deviation investigation and changed control,
5.Oversee the investigation, documentation and communication of GMP nonconformity and enforce CAPA.
6.Recruiting and training QA staffs
7.Provide GMP training to all Cell Therapy operations employees
8.Manage any regulatory agency audit and customer audit

2000年成立于上海，是中国领先的制药和生物制药研发服务供应商。该公司以新药研发为首任，以满足客户需求为宗旨，向全球制药公司和生物制药公司提供全方位、一体化的实验室研发和研究生产服务。服务范围从药物研发化学服务到生物服务，再到用于研发的大规模原料药的生产，一应俱全。